Otero-Fernández Rafael, Gómez-Outes Antonio, Martínez-González Javier, Rocha Eduardo, Fontcuberta Jordi
Department of Orthopaedic Surgery & Trauma, Hospital Clínico San Carlos, Madrid.
Clin Appl Thromb Hemost. 2008 Jan;14(1):75-83. doi: 10.1177/1076029607303962. Epub 2007 Sep 25.
The authors conducted a prospective, open, multicenter, observational study to audit the utilization patterns of bemiparin in orthopedic patients in daily clinical practice. They analyzed rates of documented symptomatic venous thromboembolism (VTE) (deep vein thrombosis and pulmonary embolism) confirmed by objective methods, major bleeding, death, thrombocytopenia, and other adverse events. It was also intended to analyze the influence of concomitant factors (bemiparin dose, concomitant medications, age, and obesity) on VTE and bleeding rates. A total of 7959 patients were included and received bemiparin for 28 days (median). Bemiparin 3500 IU/d was used in 84.9% of patients, whereas bemiparin 2500 IU/d was administered to 15.1% of patients. Reason for prophylaxis (number of cases [%]) included cast immobilization of the leg (2052 [25.8%]), knee replacement (1082 [13.6%]), hip replacement (876 [11.0%]), hip fracture surgery (437 [5.5%]), other lower limb surgery (1569 [19.7%]), knee arthroscopy (769 [9.7%]), and spine surgery (231 [2.9%]). A total of 943 patients with insufficient data on reason for prophylaxis and 560 patients with no outcome assessment were excluded from the analysis of clinical outcomes. Among 6456 assessable patients, the authors found a low rate of documented symptomatic VTE (0.91%), major bleeding (0.17%), deaths (0.37%), and mild to moderate thrombocytopenia (0.51%). None of the major bleedings was fatal or occurred in a critical organ. There were 3 deaths in which fatal pulmonary embolism (PE) could not be ruled out. There were no cases of severe type-II thrombocytopenia. VTE rates were not increased in obese patients, and major bleeding rates were not increased in elderly patients or in patients taking nonsteroidal anti-inflammatory drugs. In conclusion, bemiparin prophylaxis, given for 3 to 4 weeks in cast immobilization of the leg and other orthopedic procedures, was associated with low rates of VTE, bleeding, and other adverse events in normal clinical practice.
作者开展了一项前瞻性、开放性、多中心观察性研究，以审核日常临床实践中骨科患者使用贝米肝素的模式。他们分析了通过客观方法确诊的有症状静脉血栓栓塞（VTE）（深静脉血栓形成和肺栓塞）、大出血、死亡、血小板减少及其他不良事件的发生率。该研究还旨在分析伴随因素（贝米肝素剂量、伴随用药、年龄和肥胖）对VTE和出血发生率的影响。总共纳入7959例患者，接受贝米肝素治疗28天（中位数）。84.9%的患者使用3500 IU/d的贝米肝素，而15.1%的患者使用2500 IU/d的贝米肝素。预防原因（病例数[百分比]）包括腿部石膏固定（2052例[25.8%]）、膝关节置换（1082例[13.6%]）、髋关节置换（876例[11.0%]）、髋部骨折手术（437例[5.5%]）、其他下肢手术（1569例[19.7%]）、膝关节镜检查（769例[9.7%]）和脊柱手术（231例[2.9%]）。总共943例预防原因数据不足的患者和560例未进行结局评估的患者被排除在临床结局分析之外。在6456例可评估患者中，作者发现有症状VTE的记录发生率较低（0.91%）、大出血（0.17%）、死亡（0.37%）以及轻度至中度血小板减少（0.51%）。所有大出血均非致命性，也未发生在关键器官。有3例死亡无法排除致命性肺栓塞（PE）。没有严重II型血小板减少的病例。肥胖患者的VTE发生率未增加，老年患者或服用非甾体抗炎药的患者大出血发生率也未增加。总之，在腿部石膏固定和其他骨科手术中给予3至4周的贝米肝素预防，在正常临床实践中与VTE、出血及其他不良事件的低发生率相关。
